FDA.reportPublic FDA data

Application 012616

Type
NDA
Sponsor
GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
004ALDACTAZIDEHYDROCHLOROTHIAZIDE; SPIRONOLACTONETABLET;ORAL25MG;25MGYesNo
005ALDACTAZIDEHYDROCHLOROTHIAZIDE; SPIRONOLACTONETABLET;ORAL50MG;50MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N012616-004ALDACTAZIDEHYDROCHLOROTHIAZIDE; SPIRONOLACTONE25MG;25MGTABLET / ORALABRLD1982-12-30
N012616-005ALDACTAZIDEHYDROCHLOROTHIAZIDE; SPIRONOLACTONE50MG;50MGTABLET / ORALRLD1982-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N012616-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N012616-004ALDACTAZIDE25MG;25MGTABLET / ORALABRLD1982-12-30a50c72e98297…
2026-08-01 22:54:322026-06N012616-005ALDACTAZIDE50MG;50MGTABLET / ORALRLD1982-12-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N012616-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Spironolactone and HydrochlorothiazideSPIRONOLACTONE AND HYDROCHLOROTHIAZIDEPrasco Laboratories9d350fa2-d568-4970-a7a5-d128ff5d0a2f2026-02-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 012616
application number: NDA012616
ndc (product): 66993-188

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0025-1011ALDACTAZIDEspironolactone and hydrochlorothiazideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1011ALDACTAZIDEspironolactone and hydrochlorothiazidePfizer Laboratories Div Pfizer IncNDACurrent
0025-1011ALDACTAZIDEspironolactone and hydrochlorothiazidePfizer Laboratories Div Pfizer IncNDACurrent
0025-1011ALDACTAZIDEspironolactone and hydrochlorothiazideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1011ALDACTAZIDEspironolactone and hydrochlorothiazidePfizer Laboratories Div Pfizer IncNDACurrent
0025-1011ALDACTAZIDEspironolactone and hydrochlorothiazidePfizer Laboratories Div Pfizer IncNDACurrent
0025-1021ALDACTAZIDEspironolactone and hydrochlorothiazideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1021ALDACTAZIDEspironolactone and hydrochlorothiazidePfizer Laboratories Div Pfizer IncNDACurrent
0025-1021ALDACTAZIDEspironolactone and hydrochlorothiazidePfizer Laboratories Div Pfizer IncNDACurrent
0025-1021ALDACTAZIDEspironolactone and hydrochlorothiazideG.D. Searle LLC Division of Pfizer IncNDACurrent
0025-1021ALDACTAZIDEspironolactone and hydrochlorothiazidePfizer Laboratories Div Pfizer IncNDACurrent
0025-1021ALDACTAZIDEspironolactone and hydrochlorothiazidePfizer Laboratories Div Pfizer IncNDACurrent
59762-5014Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5014Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5014Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5014Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-5014Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazideGreenstone LLCNDA AUTHORIZED GENERICCurrent
66993-188Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazidePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-188Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazidePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-188Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazidePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-188Spironolactone and Hydrochlorothiazidespironolactone and hydrochlorothiazidePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84180SUPPL 2025-11-18
84178SUPPL 2025-11-17
72972SUPPL2022-12-21
72970SUPPL2022-12-21
66323SUPPL2021-02-23
66316SUPPL2021-02-22
64435SUPPL2020-08-27
64388SUPPL2020-08-24
57249SUPPL2019-01-18
57247SUPPL2019-01-18
10818SUPPL2014-10-24
33089SUPPL2014-03-07
12026SUPPL2014-03-07
33088SUPPL2014-01-22
12025SUPPL2014-01-21
10817SUPPL2013-06-18
12024SUPPL2013-06-13
12023SUPPL2011-09-26
12022SUPPL2011-05-24
10816SUPPL2011-05-23